(3) Regional cancer registry means the organization authorized to receive and collect cancer data for a designated area of the state and which maintains the system by which the collected information is reported to the Department.

(4) Cancer means all malignant neoplasms, including carcinoa in situ, which are specified in Volume I of the 1986 California Cancer Reporting System Standards and as set forth in the International Classification of Diseases for Oncology Field Trial Edition 1986.

(5) Case means a cancer diagnosis for an individual who is either a resident of the designated area of the regional cancer registry, regardless of where the individual was treated or diagnosed, or seen at a cancer reporting facility, other facility or by a physician within the designated area of the regional cancer registry, regardless of where the individual resides.

(6) Active follow-up program means a system for determining the vital status of each reported case no later than twelve months after the date of the last reported contact. This date is defined in Volume I of the 1986 California Cancer Reporting System Standards.

(7) Cancer reporting facility means a hospital or other facility which treats or diagnoses cancer and is also one of the following:

(A) A facility currently licensed as a health facility under the provisions of Chapter 2, commencing with Section 1250, of Division 2 of the Health and Safety Code;

(B) A surgical clinic licensed under Chapter 1, Section 1204, of Division 2 of the Health and Safety Code;

(C) A facility covered by the provisions of Section 1206, except for subsection (f), of the Health and Safety Code which, while not licensed as a clinic, is operated for the predominant purpose of diagnosing or treating cancer or where a minimum of 100 or more cancer cases are diagnosed or treated in a year.

(8) Quality Control System means operational procedures by which the accuracy, completeness and timeliness of the information reported to the Department can be determined and verified. These criteria are defined in Volume I of the 1986 California Cancer Reporting System Standards.

(9) Certified Tumor Registrar (CTR) means the designation given to individuals who pass the certification examination given by the National Tumor Registrars Association (NTRA).

(10) Population-based means that all cases are drawn from a defined population of known size and characteristics, usually one within a defined geographic area.

(11) Cancer incidence data means information on new cases of cancer including the required data listed in the 1986 California Cancer Reporting System Standards and counts of these cases by their characteristics such as age, sex and ethnicity, and by anatomic site and morphology.

(13) Modeled after the Cancer Surveillance Program of Orange County means a population-based registry that collects treatment data, has a phased implementation, collects follow-up data, has a community advisory component and receives data in a machine-readable format from cancer reporting facilities as defined in subsection (a)(7) above.

(b) Reporting requirements. The Director shall designate cancer as a disease to be mandatorily reported for all counties within the State. All counties shall be assigned to a designated regional cancer registry. When the Director designates cancer as a disease to be mandatorily reported within an area, the Director shall designate the initial mandatory reporting period, which may be less than a full calendar year, for which the regional registry will submit cases to the Department.

(1) A regional cancer registry shall establish and maintain a cancer reporting system which is able to report 97 percent of the incident cases in the initial designated reporting period and each calendar year.

(2) The regional cancer registry shall have suitable arrangements to obtain data for reporting resident cases diagnosed or treated outside the designated area of the regional cancer registry.

(3) The regional cancer registry shall report to the Department all cases diagnosed or treated in a calendar year or initial reporting period within twelve months after the close of that calendar year or initial reporting period.

(5) The regional cancer registry shall report to the Department all follow-up information provided by cancer reporting facilities with an active follow-up program no later than six months after the cancer reporting facility provides the information to the regional registry. In addition, each regional registry shall implement within three years of the designation of mandatory cancer reporting for the region a program of active follow-up for all resident cases not otherwise being followed by a cancer reporting facility. The results of the active follow-up program of the regional registry shall be reported to the Department quarterly.

(6) Data submitted to the Department by the regional cancer registry shall be in machine-readable form. The format and codes used shall be as specified by the Department.

(7) The regional cancer registry shall maintain a system of quality control in accordance with procedures approved by the Department.

(8) Representatives of the Department shall have access to the source data and the stored data in the regional cancer registry for the purpose of quality control assessments. This includes access to all cancer records maintained by a reporting facility, physician, individual or agency providing diagnostic or treatment services to cancer patients within the region.

(9) The regional cancer registry shall maintain confidentiality of data as required in Section 211.5, Health and Safety Code, and shall maintain a security system for records which contain identifying data. This system shall be reviewed and approved by the Department.

(10) When cancer is designated a reportable disease in a region, the corresponding regional cancer registry shall inform the public that cancer has been designated as a disease required to be reported in that region and that each patient diagnosed or treated with a Reportable Neoplasm will be reported to the Department as required by law.

(11) Cancer reporting facilities within a reporting region shall report to the regional cancer registry the required data as listed in Volumes I and III of the 1986 California Cancer Reporting System Standards. These reports shall conform to Volumes I, II and III of the 1986 California Cancer Reporting System Standards. When a cancer reporting facility fails to produce reports meeting the standards cited above, the regional cancer registry may perform the data collection and collect compensation from the facility for the activity at cost.

(12) Cancer reporting facilities shall report to their regional cancer registry each reportable case within six months of the time the case comes under the care of, or is admitted to, the facility.

(13) Cancer reporting facilities with an active follow-up program shall report follow-up information to the regional cancer registry no less frequently than quarterly.

(14) A facility not already defined as a cancer reporting facility under these regulations which diagnoses or treats cancer and is a primary care clinic as defined in Section 1204, Health and Safety Code or an acute psychiatric hospital as defined in Section 1250, Health and Safety Code shall report each cancer case to its regional cancer registry, or to the local health department, the choice to be determined by the regional registry, using the Confidential Morbidity Report (Form PM-110), shown below, within 30 days of the date the patient is admitted to the facility or treated in the facility for the first time. These reports shall conform to California Cancer Reporting System Standards, Volume IV.

(15) Physicians and surgeons caring for cancer patients not referred to a facility defined as a cancer reporting facility under these regulations shall report each cancer case to the regional cancer registry or to the local health department, the choice to be determined by the regional registry, using the Confidential Morbidity Report (PM-110), within 30 days of seeing the patient for the cancer for the first time. These reports shall conform to California Cancer Reporting System Standards, Volume IV.

(16) Cancer reporting facilities shall submit their cancer cases and follow-up information to the regional cancer registry in machine-readable form. The format and codes used shall be as specified by the Department in the 1986 California Cancer Reporting System Standards Volume II.

(17) Cancer reporting facilities may elect to have the regional cancer registry staff do the cancer data collection. They may do so by a contract with the regional cancer registry to identify and report the cancer cases with the facility reimbursing the regional registry for that registry's expense.

(18) Cancer reporting facilities and physicians shall employ a mechanism to ensure that their patients are informed that cancer has been designated a reportable disease and that the facility will report each patient with cancer to the Department as required by law. Patient information sheets for this purpose will be supplied to physicians by the Department.

(c) Staffing. The identification and collection of cancer data in the regional cancer registries and cancer reporting facilities shall be performed by Certified Tumor Registrars (CTR) or staff eligible to take the certification examination.

(d) Training and Credentialing Period. Reporting facilities so requesting upon application to the regional registry, may be granted a credentialing period of up to 24 months for the purpose of obtaining training to meet the requirements set forth in subsection (c) above. No credentialing period may be granted to extend beyond 30 months from the effective date of mandatory cancer reporting for the region or beyond July 1, 1990. During a credentialing period the reporting facility must meet the quality and other reporting standards. It is the responsibility of the Department, which may be carried out by the regional cancer registries, to assure that adequate tumor registrar training resources are available for no less than 24 months following the initiation of mandatory reporting in a region.

(e) Designation of Agent. The Director may designate and contract with any agency to act as the Department's agent for the maintenance of the regional cancer registry. The designated agent shall comply with all regulations for the regional cancer registry.

(f) Revocation of Designation. The Director shall have the authority to revoke the designation as Departmental agent. Revocation shall be effective no sooner than 30 days after a written notice to revoke the designation has been served.